Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
Rehabilitation, ECMO
Brief summary
Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 100 ICU patients. The effect of the intervention on mortality, health status, and function at 180 days will be evaluated, as well as cost-effectiveness. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Detailed description
The trial is a 100-patient, multicentre, randomised, controlled, parallel-group, two-sided superiority trial that will randomly allocate eligible patients to early rehabilitation or standard care in a 1:1 ratio to determine if early rehabilitation of critically ill patients receiving ECMO reduces disability when compared with standard care. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Interventions
OTHEREarly Rehabilitation
The intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation.
Sponsors
Monash University
National Health and Medical Research Council, Australia
Australian and New Zealand Intensive Care Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded outcome assessor - blinded / different therapist (strength) and central follow-up for blinded assessment of PROMs
Intervention model description
1;1 allocation, stratified by site,
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is on ECMO and expected to remain on ECMO for at least 24 hours 2. Patient is aged 18 years or older. 3. Patient was functionally independent prior to the current admission. 4. Patient is eligible for Medicare (Australian sites only).
Exclusion criteria
1. Patient has been receiving ECMO for more than 72 hours. 2. Patient has been in ICU for more than 5 days. 3. Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury. 4. Death is deemed imminent by the treating clinician. 5. Patient has a documented medical diagnosis of cognitive impairment e.g. dementia. 6. Patient was unable to mobilise prior to this admission. 7. Patient is unable to communicate in local language. 8. Patient is known to be pregnant. 9. Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated 10. The treating clinician does not believe it is in the best interests of the patient to participate in the study 11. Patient who has a bidirectional cannula in situ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 180 days post randomisation | The Modified Rankin Scale (mRS) is a 7-level ordered categorical scale capturing levels of patient disability and dependence, with scores ranging from 0 (no disability) to 6 (dead). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength at day 14 (Medical Research Council Sum-Score) | 14 days post randomisation | Grade 0 to Grade 5 where Grade 5 is the best outcome |
| ECMO-free days to day 28 | 28 days post randomisation | — |
| Organ failure free days to day 28 | 28 days post randomisation | — |
| Delirium-free days to day 28 | 28 days post randomisation | — |
| Activities of Daily Living (ADL) at hospital discharge | up to day of hospital discharge, an average of 3 months | — |
| Length of stay on ECMO, in ICU and in hospital | up to day of stay on ECMO, ICU and hospital, an average of 3 months | — |
| Mortality rate at ICU and hospital discharge, day 90 and day 180 | up to 180 days post randomisation | — |
| Montreal Cognitive Assessment (MoCA-Blind) | 180 days post randomisation | Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points. |
| WHO Disability Assessment Schedule 2.0 at day 180 | 180 days post randomisation | Scoring 10-48 are likely to have clinically significant disability. |
| Health related quality of life (EQ5D-5L) at day 180 | 180 days post randomisation | Level of severity 1 to 5 where 5 is the most severe |
| Daily longitudinal ordinal organ support outcome to day 28 | 28 days post randomisation | This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive |
| Healthcare costs at day 180 | 180 days post randomisation | Index hospital admission costs will be determined using clinical costing systems at each participating site. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital). |
| Cost-effectiveness at day 180 | 180 days post randomisation | The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days. |
| Instrumental activities of daily living at 180 days | 180 days post randomisation | Physical function measured with instrumental activities of daily living |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 28 days post randomisation | Number of patients who suffered adverse events and serious adverse events such as fall, heart attack or new or increased oozing around cannulae during rehabilitation. |
Countries
Australia, Canada
Outcome results
None listed